Quality Standards for Patients Treated by PCI. Peter F Ludman

Transcription

1 Quality Standards for Patients Treated by PCI Peter F Ludman

2 NO CONFLICT OF INTEREST TO DECLARE

3 Quality Standards for Patients treated by PCI Caution about standards Overall Structure for assessing outcomes What are Quality Standards Options for Standards

4 Quality Standards for Patients treated by PCI Caution about standards Overall Structure for assessing outcomes What are Quality Standards Options for Standards

5 Robert Liston

6 Robert Liston 1 st Professor of Surgery UCL 1 st Operation under GA in Europe Prior to anaesthetics: Speed Pain Survival Quality = Speed the fastest knife in the West End. He could amputate a leg in 2 ½ minutes

7 Robert Liston A High Quality Service? Results: Amputation 2 ½ minutes Patient died from gangrene Assistant s fingers inadvertently cut through Assistant died from gangrene Cut coat tails of distinguished surgical spectator Died of fright

8 Trolley waits It is unacceptable that some patients have to wait on trolleys before being admitted to hospital 2000 target Trolley wait to < 12 hr 2004 target Trolley wait < 4 hours

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10 Target reports Inadequate resource Creativity Patients held in ambulances clock doesn't start

11 England Time spent in A&E

12 Local Variation in Pattern National pattern Extremes

13 England Time spent in A&E

14 England Time spent in A&E

15 England Time spent in A&E 66% of all patients are sent to ward in last 10 min of 4 hours deadline? Correct decision? Correct wards

16 Measurement of Quality Aim Highest quality of care for patients Outcomes are the true measure of quality But No single outcome captures results of care Measures may be too narrow single department / single intervention May destabilize care in unmeasured area Measures may be too broad entire hospital rates of acquired infection Measure of process are convenient but surrogates Measurement leads to gaming

17 Quality Standards for Patients treated by PCI Caution about standards Overall Structure for assessing outcomes What are Quality Standards Options for Standards

18 Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Tier 2 Tier 3 Health Status Achieved or Retained Process of recovery Sustainability of health Survival Degree of Health or recovery Time to recovery and return to normal activity Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy

19 Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Tier 2 Tier 3 Health Status Achieved or Retained Process of recovery Sustainability of health Survival Degree of Health or recovery Time to recovery and return to normal activity Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy

20 Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Tier 2 Tier 3 Health Status Achieved or Retained Process of recovery Sustainability of health Survival Degree of Health or recovery Time to recovery and return to normal activity Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy

21 Outcome Measurement Hierachy Porter NEJM 2010;363:2477 Tier 1 Tier 2 Tier 3 Health Status Achieved or Retained Process of recovery Sustainability of health Survival Degree of Health or recovery Time to recovery and return to normal activity Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy

22 Outcome Measurement Hierachy Survival Degree of Health or recovery Time to recovery and return to normal activity Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy Mortality post procedure Risk adjustment Functional level CCS class / QoL measures Time to referral / to investigation to Rx / to recovery post Rx / time to return to normal activities / return to work MACCE / delay to emergency Rx / pain / access site comps / drug side effects / appropriateness of Rx / medical errors Maintained freedom from symptoms / need for repeat PCI / staged procedures Stent thrombosis / drug side effects

23 Features for Outcome measures Important to patients Occurrence sufficiently frequent Features to incorporate entire hierarchy Practical issues regarding measurement Care with measures that encourage gaming Objective, standardised and clearly defined Methods for gathering data

24 Quality Standards for Patients treated by PCI Caution about standards Overall Structure for assessing outcomes What are Quality Standards Options for Standards

25 White Paper July 2010

26 Equity and Excellence: Liberating the NHS

27 Quality Standards

28 Quality Standards Specific concise statements that: Act as markers of high quality, cost-effective patient care across a pathway or clinical area Derived from best available evidence Produced collaboratively with NHS and social care, with their partners and service users

29 National Quality Board Established 2009 Champion quality and ensure alignment in quality throughout NHS Multi-stakeholder board

30 National Quality Board

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32 NQB Prioritisation Committee Ministers Refer topics to NICE NICE topic Expert Group Draw up draft standards based on NICE guidance and other NHS accredited sources 6/52 Field testing consultation NICE Quality Standards Program Board NICE Guidance Executive Published on NICE website

33 Use of Quality Standards Patients and Public Information regarding the quality of care they can expect to receive Clinical staff Ensure care provided is based on latest evidence and best practice Audit Governance Professional development and revalidation Provider organisations A framework for Quality Accounts Assess the quality of care being delivered Highlight areas for improvement and monitor changes Commissioners Ensure best care being delivered via contracting process Incentive payments (Commissioning for quality improvement CQUIN) Demonstration of World Class commissioning competencies

34 Quality Standards for Patients treated by PCI Caution about standards Overall Structure for assessing outcomes What are Quality Standards Options for Standards

35 NICE guidance so far Technology Appraisals Drug Eluting Stents TA 152 (July 2008) DES if artery < 3 mm diameter or lesion > 15mm long Price difference between BEM and DES <= 300 Prasugrel in ACS TA 182 (Oct 2009) Primary PCI Stent thrombosis on clopidogrel Diabetics with ACS MPI TA73 (Nov 2003) partially updated Recommended Ix if established CAD and Sx post MI of after revasc Thrombolysis TA52 (Oct 2002)

36 NICE guidance so far Technology Appraisals Drug Eluting Stents TA 152 (July 2008) DES if artery < 3 mm diameter or lesion > 15mm long Price difference between BEM and DES <= 300 Prasugrel in ACS TA 182 (Oct 2009) Primary PCI Stent thrombosis on clopidogrel Diabetics with ACS MPI TA73 (Nov 2003) partially updated Recommended Ix if established CAD and Sx post MI of after revasc Thrombolysis TA52 (Oct 2002) BCIS dataset Single lesions only

37 NICE guidance so far Technology Appraisals in Progress Ticagraor for ACS (July 2011) Bivalirudin for STEMI (?)

38 NICE guidance so far Clinical Guidelines Secondary Prevention CG48 (May 2007) Life style / Rehab / Medication / Ix / Revasc Chest pain recent onset CG95 (March 2010) Acute Mx based on diagnosis, timing of pain, Tn, ECG Stable CAD likelihood 10-29% Coro Ca 2+ Ix other cause / 64 CT/ angio 30-60% functional imaging 61-90% angiography

39 NICE guidance so far Clinical Guidelines (cont) UA and NSTEMI CG94 (March 2010)

40 NICE guidance so far Clinical Guidelines (cont) UA and NSTEMI CG94 (March 2010) Grace Score > 3%

41 NICE guidance so far Clinical Guidelines (cont) UA and NSTEMI CG94 (March 2010) Grace Score > 3% Cath < 96 hrs MDT Consider: 2b-3a / bival

42 NICE Currently limited World literature ESC and AHA Guidelines

43 Stable v ACS Stable angina Symptoms ACS Recurrent events Mortality

44 Outcome Measurement Hierachy Survival Degree of Health or recovery Time to recovery and return to normal activity Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy Mortality post procedure Risk adjustment Functional level CCS class / QoL measures Time to referral / to investigation to Rx / to recovery post Rx / time to return to normal activities / return to work MACCE / delay to emergency Rx / pain / access site comps / drug side effects / appropriateness of Rx / medical errors Maintained freedom from symptoms / need for repeat PCI / staged procedures Stent thrombosis / drug side effects

45 Outcome Measurement Hierachy Survival Degree of Health or recovery Time to recovery and return to normal activity Stable angina Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy Mortality post procedure Risk adjustment Functional level CCS class / QoL measures Time to referral / to investigation to Rx / to recovery post Rx / time to return to normal activities / return to work MACCE / delay to emergency Rx / pain / access site comps / drug side effects / appropriateness of Rx / medical errors Maintained freedom from symptoms / need for repeat PCI / staged procedures Stent thrombosis / drug side effects

46 Outcome Measurement Hierachy Survival Degree of Health or recovery Time to recovery and return to normal activity Stable angina Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy Mortality post procedure Risk adjustment Functional level CCS class / QoL measures Safety and Symptoms Time to referral / to investigation to Rx / to recovery post Rx / time to return to normal activities / return to work MACCE / delay to emergency Rx / pain / access site comps Patient / drug side effects Reported / appropriateness of Rx / medical errors Outcome Measures Maintained freedom from symptoms / need for repeat PCI / staged procedures Stent thrombosis / drug side effects

47 Outcome Measurement Hierachy Survival Degree of Health or recovery Time to recovery and return to normal activity ACS Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy Mortality post procedure Risk adjustment Functional level CCS class / QoL measures Time to referral / to investigation to Rx / to recovery post Rx / time to return to normal activities / return to work MACCE / delay to emergency Rx / pain / access site comps / drug side effects / appropriateness of Rx / medical errors Maintained freedom from symptoms / need for repeat PCI / staged procedures Stent thrombosis / drug side effects

48 Outcome Measurement Hierachy Survival Degree of Health or recovery Time to recovery and return to normal activity ACS Disutility of care or treatment process Sustainability of health & nature of recurrences Long term consequences of therapy Mortality post procedure Risk adjustment Functional level CCS class / QoL measures Time to referral / to investigation to Rx / to recovery post Rx / time to return to normal activities / return to work Safety and Process MACCE / delay to emergency Rx / pain / access site comps / drug side effects / appropriateness of Rx / medical errors Maintained freedom from symptoms / need for repeat PCI / staged procedures Stent thrombosis / drug side effects

49 Key Quality Standards Safety Major Averse Events Risk adjusted

50 Key Quality Standards Safety Major Averse Events Risk adjusted Elective Symptoms and Quality of Life ACS (non-stemi) Structure / appropriateness / process STEMI Speed

51 % UK MINAP Data McLenachan for NHS Improvement Heart /2 2008/3 2008/4 2009/1 2009/2 2009/3 2009/4 2010/1 Primary PCI Lysis

52 Mortality % PPCI Delay 120 Early presenters High risk Late presenters Low risk No Rx PPCI (120 min delay) Time delay to presentation / Rx

53 PPCI Symptom to Balloon PPCI, n=1791 De Luca Circ 2004;109: year mortality is increased by 7.5% for each 30 minute delay

54 PPCI Door to Balloon Delay National Registry of Myocardial Infarction n=29,222 McNamara JACC 2006:47;2180 High risk Anterior DM HR>100 BP<100 Low risk

55 PPCI Door to Balloon Delay NRMI, n=29,222 Relative Risk per extra 15-Minutes DTB time Compared with DTB of 90 Minutes McNamara JACC 2006:47;2180 adapted by Nalamothu

56 PPCI Door to Balloon Delay NRMI, n=29,222 McNamara JACC 2006:47;2180 adapted by Nalamothu Relative Each Risk per 15-minute extra 15-Minutes Door-to-Balloon DTB time time Compared with DTB was of associated 90 Minuteswith 6.3 fewer deaths per 1000 patients

57 Timings in PPCI Terkelsen JAMA 2010;304:763 Onset of STEMI FMC Reperfusion Patient delay EMS delay 15 min Transport to PCI centre DTB System Delay

58 PPCI System Delay Western Denmark n=6,209 Terkelsen JAMA 2010;304:763 Cum Mortality 30.8% 28.1% 23.3% 15.4%

59 PPCI Mortality v Pre Hospital Δ Sorensen EHJ Dec /eurheartj/ehq437 Aarhus County Denmark Urban and Rural implementation of Pre Hospital Diagnosis System delay Pre Hospital Diagnosis: No Pre Hospital Diagnosis: 92 min 153 min Δ 1 hour

60 PPCI Mortality v Pre Hospital Δ Sorensen EHJ Dec /eurheartj/ehq437 Aarhus County Denmark, System delay Δ 38 min Δ 74 min

61 PPCI Mortality v Pre Hospital Δ Sorensen EHJ Dec /eurheartj/ehq437

62 PPCI Mortality v Pre Hospital Δ Sorensen EHJ Dec /eurheartj/ehq437 All cause Mortality median of 4.3 yr FU 31 v 18% Pre-hospital diagnosis HR after adjustment = 0.68

63 PPCI Call to Balloon time By Admission Route data: Ludman 200 Median CTB min (+/- IQR) Direct IHT ALL

64 PPCI Call to Balloon time By Admission Route Median CTB min (+/- IQR) % Direct v 26.1% IHT data: Ludman 50 0 Direct IHT ALL

65 Conclusion Overview of the politics of Quality Standards Clinical governance and quality of patient care is underpinned by standards Not measured not assessed Once measured inevitable change in its value Many hidden traps to what you measure and how you use it to improve a service

66 The End